The Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Female Participants With Interstitial Cystitis /Bladder Pain Syndrome (MK-7264-005)

Bladder Pain Syndrome Clinical Trial

Official title:

A Four-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01569438
• Other study ID #: 7264-005
• Secondary ID: AF219-005MK-7264
• Status: Terminated
• Phase: Phase 2
• Start date: April 13, 2012
• Est. completion date: May 14, 2014

Study information

• Verified date: August 2020
• Source: Afferent Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of gefapixant (AF-219/MK-7264) in female participants with moderate to severe pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) after 4 weeks of treatment.

Description:

This study is a double-blind, placebo-controlled, randomized trial designed to assess the efficacy and safety of gefapixant in female participants with moderate to severe pain associated with IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and Follow-up.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 107
• Est. completion date: May 14, 2014
• Est. primary completion date: May 1, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Women

• Women of child bearing potential must not be pregnant during the study and must use two forms of birth control

• Clinical evidence of Interstitial Cystitis /Bladder Pain Syndrome (IC/BPS)

• Have provided written informed consent

Exclusion Criteria:

• History of diseases that can be confused for IC/BPS

• Unable to void spontaneously

• Immunosuppressant, intravesicular, nerve stimulator or opioid treatment for certain periods prior to start of the study

• Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1 antagonist, or anti-muscarinic treatment within a certain period prior to the start of the study

Related Conditions & MeSH terms

• Bladder Pain Syndrome
• Cystitis
• Cystitis, Interstitial
• Somatoform Disorders
• Syndrome

Intervention

Drug:
• Gefapixant
50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks
• Placebo
Dose matched placebo tablets, BID, orally, with food for 4 weeks

Locations

Country	Name	City	State
United States	Afferent Investigative Site	Albuquerque	New Mexico
United States	Afferent Investigative Site	Ann Arbor	Michigan
United States	Afferent Investigative Site	Annapolis	Maryland
United States	Afferent Investigative Site	Bala-Cynwyd	Pennsylvania
United States	Afferent Investigative Site	Boynton Beach	Florida
United States	Afferent Investigative Site	Brooklyn	New York
United States	Afferent Investigative Site	Cincinnati	Ohio
United States	Afferent Investigative Site	Cleveland	Ohio
United States	Afferent Investigative Site	Coeur d'Alene	Idaho
United States	Afferent Investigative Site	Dallas	Texas
United States	Afferent Investigative Site	Farmington	Connecticut
United States	Afferent Investigative Site	Fort Worth	Texas
United States	Afferent Investigative Site	Glendale	Alabama
United States	Afferent Investigative Site	Glendora	California
United States	Afferent Investigative Site	Grand Rapids	Michigan
United States	Afferent Investigative Site	Greenville	North Carolina
United States	Afferent Investigative Site	Homewood	Alabama
United States	Afferent Investigative Site	Houston	Texas
United States	Afferent Investigative Site	Hyde Park	New York
United States	Afferent Investigative Site	Idaho Falls	Idaho
United States	Afferent Investigative Site	Irving	Texas
United States	Afferent Investigative Site	Kalamazoo	Michigan
United States	Afferent Investigative Site	Lancaster	Pennsylvania
United States	Afferent Investigative Site	Meridian	Idaho
United States	Afferent Investigative Site	Mobile	Alabama
United States	Afferent Investigative Site	Murrieta	California
United States	Afferent Investigative Site	Myrtle Beach	South Carolina
United States	Afferent Investigative Site	New Britain	Connecticut
United States	Afferent Investigative Site	Phoenix	Arizona
United States	Afferent Investigative Site	Plantation	Florida
United States	Afferent Investigative Site	Royal Oak	Michigan
United States	Afferent Investigative Site	Salisbury	North Carolina
United States	Afferent Investigative Site	Salt Lake City	Utah
United States	Afferent Investigative Site	San Diego	California
United States	Afferent Investigative Site	San Diego	California
United States	Afferent Investigative Site	Shreveport	Louisiana
United States	Afferent Investigative Site	Tiffin	Ohio
United States	Afferent Investigative Site	Virginia Beach	Virginia
United States	Afferent Investigative Site	Voorhees	New Jersey
United States	Afferent Investigative Site	Winston-Salem	North Carolina
United States	Afferent Investigative Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Afferent Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Average Mean Numeric Pain Rating Scale (NPRS) Score at Week 4	The bladder pain severity was measured using 0-10 NPRS, with 0 representing 'no pain' and 10 representing 'the worst pain possible'. Participants were asked to select a number on the scale that best described the severity of bladder pain during past 24 hours over telephone using an interactive voice response system (IVRS) every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The primary analysis was conducted using a Mixed Model with Repeated Measures (MMRM) approach to calculate the Least Squares (LS) mean change from baseline in NPRS score and associated Standard Error (SE) at Week 4 for each treatment arm. Negative values indicate decrease in bladder pain severity.	Baseline and Week 4
Secondary	Change From Baseline in Painful Bladder/Interstitial Cystitis Symptom Diary (PBIC-SD) Score at Week 4	To assess the severity of bladder pain syndrome (BPS), an 8-item participant self-report PBIC-SD measure was used. Participants were asked to select a number on the scale that best described the severity of bladder pain over telephone using an IVRS each evening on the three consecutive days (during the Baseline Assessment Phase and during each Treatment Week up to 4 weeks). Each item was graded on a scale from 0 (good condition) to 4 (poor condition) with a total score range 0-32. Higher scores indicate more severe BPS. The analysis was conducted using a MMRM approach to calculate the LS mean change from baseline PBIC-SD total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.	Baseline and Week 4
Secondary	Change From Baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score at Week 4	To measure the severity of BPS (urgency and frequency of urination, nighttime urination, and pain or burning) over past month, a 4-item self-report ICSI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The ICSI score range from 0 (Not at all) to 5 (Almost always) for the first 3 items and a score of 0 (Not at all) to 4 (Almost always) for the last item, with an index score range of 0-19. Higher scores indicate more severe BPS. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline ICSI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in severity of BPS.	Baseline and Week 4
Secondary	Change From Baseline in Genitourinary Pain Index (GUPI) Score at Week 4	To measure the degree of genitourinary pain symptoms, an 8-item self-report GUPI measure was used. Participants were asked to select a number on the scale that best described the severity of symptoms over telephone using an IVRS every evening at bedtime during the baseline assessment phase and treatment phase (up to 4 weeks). The GUPI instrument yields a total score of 0-45 and 3 subscales: pain (score = 0-23), urinary (score = 0-10), and quality of life (score = 0-12). Higher scores indicate more severe symptoms. The analysis was conducted using one-way ANCOVA model to calculate the LS mean change from baseline GUPI total score and associated SE at Week 4 for each treatment arm. Negative values indicate decrease in degree of genitourinary pain symptoms.	Baseline and Week 4